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FDA Panel Says Painkiller Dosage Should Be Reduced

More than 35 government experts voted 21-16 yesterday to reduce the maximum dosage of 4 grams for combination cold medications with acetaminophen, including Tylenol.

ADELPHI, Md. — More than 35 government experts voted 21-16 here yesterday to reduce the maximum dosage of 4 grams for combination cold medications with acetaminophen, including Tylenol.

They also voted 24-13 to limit the single dosage of such medication to 650 milligrams compared to the current single dosage of 1,000 milligrams.

The panel at the two-day meeting arranged by the Food and Drug Administration voted against the proposal to pull the products off the market in order to avoid deadly overdoses.

Acetaminophen, which is in Tylenol and dozens of other prescription and over-the-counter medications, is the leading cause of liver failure in the U.S. and sends 56,000 people to the emergency room each year, according to the FDA. There are about 200 acetaminophen-related deaths annually, with 10% of those deaths linked to acetaminophen over-the-counter combination cold medications, according to the Consumer Healthcare Products Association.

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